Mucosal healing seen with infliximab biosimilar CT-P13 in ulcerative colitis

Last Updated: 2016-04-29

By Reuters Staff

NEW YORK (Reuters Health) - About two-thirds of patients
with ulcerative colitis (UC) had mucosal healing by the end of
induction treatment with the infliximab biosimilar CT-P13,
according results of the first prospective study to evaluate
this.

CT-P13 is the first biosimilar monoclonal antibody of
reference infliximab (Remicade) approved in Europe and several
other countries where it is known as Remsima. An advisory
committee to the U.S. Food and Drug Administration endorsed it
earlier this year. But until now, data on the effect of CT-P13
on mucosal healing were lacking.

To investigate, Dr. Tamas Molnar of University of Szeged in
Hungary and colleagues studied 63 UC patients (mean age 30, mean
disease duration 5.7 years) who received CT-P13 induction
therapy at three IBD clinics in Hungary and one in the Czech
Republic. Reasons for starting CT-P13 included acute, severe
flare up and chronic, refractory activity.

CT-P13 induction consisted of 5 mg/kg given as an
intravenous infusion at zero, two and six weeks followed by a
maintenance regimen of 5 mg/kg every eight weeks, except for one
Czech patient with acute severe disease who received an
induction dose of 10 mg/kg.

At baseline, the mean value of total Mayo score was 9.2,
with mean endoscopic subscore (eMayo) of 2.7 points at the
beginning of the CT-P13 therapy.

At week 14, the mean value of total Mayo score dropped to
3.4, with eMayo of 1.1. Both scores decreased significantly in
responders at week 14 compared to baseline (p<0.001 and p<0.001)

The cumulative clinical response rate was 82.5%. Steroids
could be tapered and stopped in 60% of the patients on systemic
corticosteroids at entry.

"Infliximab biosimilar CT-P13 represents a promising
treatment option for patients with UC not only regarding
clinical activity, but also in achieving mucosal healing," the
authors conclude in their paper, online April 21 in the Journal
of Crohn's and Colitis.

In a related paper in the journal, online April 19, Dr. Lisa
Smits from Radboud University Medical Centre and colleagues
report short-term clinical outcomes following a switch from
brand name infliximab to CT-P13 in a "real-life" cohort of 83
patients with inflammatory bowel disease.

The primary endpoint was disease activity at week 16 after
switching to CT-P13 relative to baseline. Secondary endpoints
included additional inflammatory, pharmacokinetic and
immunogenicity parameters, as well as quality of life and
safety. All markers were assessed at week zero and 16.

"Switching did not result in significant changes of disease
activity as corroborated by relevant and validated biomarkers,"
Dr. Smits and colleagues report. "Pharmacokinetic parameters
such as TL (trough level) of CT-P13 were maintained during the
study. Two patients developed new detectable ADA (antidrug
antibodies) and 5 patients discontinued CT-P13." There were no
unexpected safety signals.

The design of the study, which did not include a control
group that allowed patients to continue brand name infliximab,
is a limitation of the study, they note. "Therefore, it is
difficult to interpret changes in efficacy, safety and
pharmacokinetics that may be due to either the switch to CT-P13
or may be coincident with the natural course. The ongoing
NOR-SWITCH study (estimated completion date January 2017) might
be able to provide answers to some of the issues," they write.

They note that the cohort was heterogeneous in terms of
diagnosis, infusion schedule, and disease activity. "As such our
cohort reflects real world practice outside the strict in- and
exclusion criteria of randomized controlled trials, which allows
immediate translation of results to clinical care. However, the
duration of follow-up was relatively short and longer follow-up
is required to determine long-term efficacy, safety and
immunogenicity of CT-P13.

Despite these limitations, the authors say their study shows
that switching from brand name infliximab to CT-P13 had no
marked impact on short-term clinical outcomes, suggesting that
making the switch to CT-P13 for the treatment of IBD is
"feasible."

None of the studies had commercial funding and the authors
did not report relevant conflicts of interest.